Peripheral Electrical Stimulation for Migraine Prevention

NCT03900611 | Unknown

• 1 other identifier: 2019-01-001C
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Migraine is a common and disabling disease that affects more than 10% of the population worldwide. The prevalence of migraine in Taiwan is around 9.1%. The migraineurs missed 2 workdays due to migraine per year, that is 3.7 million estimated missed workdays in total and an estimated cost of 4.6 billion New Taiwan dollars. In addition, some migraineurs have poor response to the medications or suffer from adverse effects, and may further develop medication-overuse headache. Therefore, in recent years, efforts have been made to develop non-medication treatments, and the number of studies using neuromodulation as an intervention has increased dramatically. Among them, peripheral electrical stimulation has long been a routine treatment for pain in the clinic, and research has also shown its good evidence. In addition, recent studies have shown that peripheral electrical stimulation can also alter the cortical activities. Compared with the proximal brain stimulation, the remote electrical stimulation is safer, more convenient, less expensive and suitable for home use. To date, only one research had focused on the immediate anesthetic effect of remote electrical stimulation whereas the research for migraine prevention is still absent. Therefore, we expect to utilize a more remote electrical stimulation than trigeminal nerve electrical stimulation, which is the commonly used research method nowadays, as an interventional model. In three years, we will recruit 80 migraineurs along with 40 healthy controls and investigate the effects of 8-week home-based remote electrical stimulation on the prevention of migraine and the mechanisms using brain imaging, electrophysiological and biochemical examinations. We also aim to identify the predictors of the responders to remote electrical stimulation. If the effects of remote electrical stimulation are confirmed, as a non-drug neuromodulation management with features of non-invasive, low adverse effects and high accessibility, it will greatly lower the cost of social health care and better improve the quality of life and clinical status of the migraineurs.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• change in migraine or headache days of a month in average

  change in migraine or headache days of a month in average

  2 months

• responder rate

  responder rate (50% pain reduction from baseline)

  2 months

Secondary Outcomes (10)

• change in moderate to severe headache days of a month in average

  2 months

• acute headache medication use

  2 months

• Beck Depression Inventory

  2 months

• modified Migraine Disability Scale

  2 months

• Patient/Clinical Global Impression of Change

  2 months

Study Arms (3)

Active stimulation

EXPERIMENTAL

Device: peripheral electrical stimulation

Sham stimulation

SHAM COMPARATOR

Device: peripheral electrical stimulation

healthy control

NO INTERVENTION

Interventions

peripheral electrical stimulation DEVICE

The subjects will undergo 8-week home-based peripheral electrical simulation on the median nerve. The peripheral electrical simulation will be performed once a day for 30 minutes. The stimulation will be active or sham depend on the group assignment.

Active stimulation; Sham stimulation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Migraine:
• Diagnosed as migraine by International Classification of Headache Disorder (ICHD-III) criteria
• onset before 50 years old
• yrs.
• or more migraine days per month in average
• Healthy control:
• devoid of any systemic or neurological diseases

You may not qualify if:

• history of major systemic illness, including uncontrolled hypertension, diabetes, chronic renal insufficiency, autoimmune diseases or malignancies
• history of neurological disorders which might affect sensation such as previous stroke or peripheral neuropathy
• pregnancy or lactation
• epilepsy
• moderate depressed (BDI\>20)
• using prophylactics for migraine
• other remote electrical stimulation contraindications, such as open wound, sensory impairment, metal implant
• other transcranial magnetic stimulation contraindications, such as, high intracranial pressure, cochlear implant, cranial metal implant
• other magnetic resonance imaging contraindications, such as, pacemaker, stent, metal implant, claustrophobia

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 3, 2019
• Study Start: February 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: January 29, 2021

Record last verified: 2021-01